ExoOne Bio, a subsidiary of TTY Biopharm, announced on the 25th that it has officially received approval from the Food and Drug Administration of the Ministry of Health and Welfare to become the first company in Taiwan to use human cell-derived exosomes as cosmetic ingredients. ExoOne Chairman Lin Tsou-yen stated that the company will gradually launch four products including ampoules, essences, masks, and hair care solutions in the domestic market, targeting medical aesthetics clinics, e-commerce platforms, and pharmacies. The company aims to achieve a revenue target of 50 million NT dollars in the first year and expects revenue to multiply from next year.
Founded by former Minister of Health and Welfare Tsou-yen Lin at the end of 2020, ExoOne is the only biotech company in Taiwan dedicated to exosome research and development. Its major shareholders include TTY Biopharm, Cell-Doctor, and Seaward Wool Textile.
Tsou-yen Lin emphasized that ExoOne focuses on the research and development of exosome-based drugs, with a focus on the development of drugs for degenerative diseases. Currently, the research and development progress is in the preclinical stage, with clinical indications including glaucoma, degenerative osteoarthritis, and chronic kidney disease. The recently approved "Regenerative Medicine Dual Act" by the Executive Yuan lists exosomes as cell-derived products, making it eligible for the legislation.
In December last year, the Ministry of Health and Welfare announced a draft amendment to the "List of Prohibited Ingredients for Cosmetics," conditionally allowing the use of human-derived exosomes as cosmetic ingredients. The relevant regulations were announced on March 21 this year, allowing the use of human-derived exosomes in cosmetics after individual case reviews. ExoOne is the first company to pass the review process.
Lin Tsou-yen stated that in order to continue its research efforts, ExoOne has referred to overseas exosome skincare product models and launched a skincare series with the strictest experimental data, which is superior to Korean exosome skincare products and is also Taiwan's first human exosome skincare series. The skincare series obtained International Nomenclature of Cosmetic Ingredients (INCI) certification in January this year.
For the domestic market, ExoOne will gradually introduce four products including ampoules, essences, masks, and hair care solutions to medical aesthetics clinics, e-commerce platforms, and pharmacies starting from the first half of this year. The company aims to achieve a revenue target of 50 million NT dollars in the first year, and revenue is expected to multiply from next year. For the international market, ExoOne is actively marketing exosome skincare products to countries such as Japan, the United States, and Canada, hoping to form a national team with domestic players to bring Taiwan's exosome research and industry strength to the international market.
ExoOne Bio uses the youngest umbilical cord mesenchymal stem cells to develop exclusive exosome purification and separation technologies, achieving high purity, high activity, and high yield processes that exceed international standards. It has become a benchmark case for Taiwan's Center for Drug Evaluation (CDE). In addition, the CDE drafted exosome manufacturing and control guidance principles in February this year, which will help biotech companies seize global opportunities in new drugs and vaccines.
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